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Past Event

Brookings Roundtable on Active Medical Product Surveillance: Conducting Real-Time Safety Evaluation with Medicare Data: Learnings from the SafeRx Project

Past Event

Conducting Real-Time Safety Evaluation with Medicare Data

On October 4, the Engelberg Center for Health Care Reform hosted a roundtable webinar, “Conducting Real-Time Safety Evaluation with Medicare Data: Learnings from the SafeRx Project.”

Download presentation slides » (PDF)

The roundtable featured a presentation by Dr. Judy Racoosin of the Food and Drug Administration (FDA), who discussed a study conducted in the Medicare database that evaluated the impact of lags in claim processing and claim information updates (claims adjudication) on real-time evaluation of drug safety signals. This study was performed as part of the SafeRx project, a collaboration between FDA and the Centers for Medicare & Medicaid Services to utilize Medicare data for medical product active surveillance. Mini-Sentinel collaborators – including Dr. Jeff Brown of Harvard Medical School and Harvard Pilgrim Health Care Institute, and Dr. Jennifer Nelson of Group Health Research Institute and University of Washington School of Public Health – made additional comments regarding how the Mini-Sentinel Coordinating Center will evaluate similar issues in the Mini-Sentinel Distributed Dataset.


Welcome and Introduction

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

SafeRx Project Overview and Data Limitations


Judy Racoosin

Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research

Remarks from Mini-Sentinel Collaborators

More Information


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